Regulatory UpdatesAug 30, 2026•1 min read

FDA Approves Lilly Methyltestosterone Tablet ANDA080256 (Discontinued)

By the PharmaCountry team

FDA approved Lilly's ANDA080256 for methyltestosterone tablets (10 mg and 25 mg) buccal/sublingual on Dec 22 1971; both products are now discontinued.

The U.S. Food and Drug Administration has granted approval for application ANDA080256 submitted by Eli Lilly and Company. The approval covers two methyltestosterone tablet products intended for buccal and sublingual administration, containing 10 mg and 25 mg of the active ingredient respectively. Both products are listed with a marketing status of "Discontinued." The original submission (type ORIG) received an approval status (AP) on December 22, 1971.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Methyltestosterone #ANDA080256 #FDA approval #Lilly #discontinued